Status:
COMPLETED
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Lead Sponsor:
Pfizer
Conditions:
Arthritis
Rheumatoid
Eligibility:
All Genders
17-99 years
Brief Summary
This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule ...
Detailed Description
Implemented as a Special Investigation by Central Registration System
Eligibility Criteria
Inclusion
- Patients need to be administered Rheumatrex in order to be enrolled in the survey
- Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis
Exclusion
- Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
- Patients who have been treated MTX other than Rheumatrex administered Rheumatrex
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
2860 Patients enrolled
Trial Details
Trial ID
NCT01414257
Start Date
May 1 2011
End Date
March 1 2014
Last Update
August 6 2018
Active Locations (1)
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1
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka, Japan